Ampicillin Sodium & Sulbactam Sodium

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139 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
139
Total Reports
93
Deaths Reported
6690.0%
Death Rate

Active Ingredients

Ampicillin Sodium & Sulbactam Sodium

Administration Routes

UnknownIntravenousSubcutaneous

Species Affected

Dog 124
Cat 15

Most Affected Breeds

Retriever - Labrador 33
Domestic Shorthair 12
Retriever - Golden 7
Chihuahua 5
Maltese 4
Spitz - German Pomeranian 4
Beagle 4
Deutsche Dogge, Great Dane 3
Shih Tzu 3
Terrier - Jack Russell 3

Most Reported Reactions

Vomiting 61
Death by euthanasia 57
Lethargy (see also Central nervous system depression in 'Neurological') 57
Other abnormal test result NOS 39
Elevated alanine aminotransferase (ALT) 38
Anorexia 36
Elevated serum alkaline phosphatase (SAP) 35
Death 35
Leucocytosis NOS 30
Elevated blood urea nitrogen (BUN) 30
Fever 28
Abnormal ultrasound finding 27

Outcome Breakdown

Euthanized
59 (42.1%)
Ongoing
40 (28.6%)
Died
34 (24.3%)
Recovered/Normal
4 (2.9%)
Outcome Unknown
3 (2.1%)

Data Summary

Metric Value
Total adverse event reports 139
Reports involving death 93
Case-fatality rate (reported events) 6690.0%
Distinct species in reports 2
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Ampicillin Sodium & Sulbactam Sodium Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 139 adverse event reports referencing Ampicillin Sodium & Sulbactam Sodium, including 93 reports in which the animal died — a 6690.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Ampicillin Sodium & Sulbactam Sodium. Reported administration routes include Unknown, Intravenous, Subcutaneous. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Ampicillin Sodium & Sulbactam Sodium reports are Dog (124 reports), Cat (15 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (33), Domestic Shorthair (12), Retriever - Golden (7) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Ampicillin Sodium & Sulbactam Sodium are Vomiting (61), Death by euthanasia (57), Lethargy (see also Central nervous system depression in 'Neurological') (57), Other abnormal test result NOS (39). Of the 140 reports with a coded outcome, Euthanized is the leading category at 42.1%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Ampicillin Sodium & Sulbactam Sodium.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

Related

Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial